The following data is part of a premarket notification filed by Gujarat Surgico, Ltd. with the FDA for Surgico Oxygen Mask.
| Device ID | K924069 |
| 510k Number | K924069 |
| Device Name: | SURGICO OXYGEN MASK |
| Classification | Mask, Oxygen |
| Applicant | GUJARAT SURGICO, LTD. A1, MALAV DUPLEX STADIUM COMMERCE COLLELGE ROAD Navrangpura Ahmedabad-380, IN |
| Contact | Managing Director |
| Correspondent | Managing Director GUJARAT SURGICO, LTD. A1, MALAV DUPLEX STADIUM COMMERCE COLLELGE ROAD Navrangpura Ahmedabad-380, IN |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-11 |
| Decision Date | 1993-02-04 |